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India Offers Bounty for Whistleblowers on Fake Medicines

In a mid-July circular, India’s Central Drugs Standards Control Organisation (CDSCO) announced the offer of rewards for whistleblowers who report on goods that are confirmed as “spurious, adulterated, and/or misbranded.” Rewards have been set at up to 20% of the total value of intercepted shipments of goods. The maximum value of the reward is 2.5m […]

FDA’s Sklamberg on FDASIA Title VII Implementation

In mid-July, FDA Deputy Commissioner Howard Sklamberg posted an update on the implementation of FDASIA Title VII. In the post, he lists the progress FDA has made, such as rules, guidances, meetings, and reports related to protecting the global drug supply chain. Sklamberg covered similar ground at the FDLI forum on “Understanding CGMPs: What Attorneys […]

Changes in India’s Serialization Expectations

India announced in a late June public notice that it now considers mono cartons containing strips, vials, or bottles of pharmaceutical products as secondary, rather than primary packaging, for the purposes of serialization. The Directorate General of Foreign Trade of India requires secondary packaging to carry a barcode encoding a unique product identification code, batch […]

EU Launches Genuine Online Pharmacy Logo Scheme

In late June, EC introduced a logo that will allow patients to identify authorized online pharmacies providing authentic medicines.

FDA and Customs Announce “Trusted Trader Program”

In mid-June, FDA and the US Customs and Border Protection (CBP) announced the launch of a new “Trusted Trader” program meant to expedite the import of products made by companies that are known to meet a quality selection standard. Participants in the program will be given incentives such as exemption from “non-intrusive” inspections. To qualify, participants […]

WHO Releases Storage/Transport Supplements

WHO has released for review a set of supplements on its Technical Report Series, No. 961, 2011 Annex 9, which provides a “model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products.” The supplements cover: ● temperature and humidity monitoring systems for transport operations ● temperature and humidity monitoring systems for fixed […]

FDA Issues Draft Guidance on Identifying Suspect Drugs

In early June, FDA announced the release of a draft guidance for industry on “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” This is the first guidance issued under Title II of the Drug Quality and Security Act (DQSA) (IPQ January 23, 2014). It advises drug supply chain stakeholders on how […]

FDA Holds First DQSA Track-and-Trace Workshop

The first public workshop to discuss the implementation of track and trace provisions of title II of the Drug Quality and Security Act (DQSA) was held May 8-9. The workshop was designed to gather information, current practices, research, and ideas on the standard documentation that should be conveyed as products move down the supply chain. […]

Pew Releases Study Findings on Implementing a Track-and-Trace System

In order to better understand the difficulties related to the implementation of a track-and-trace supply chain system, Booz Allen Hamilton and The Pew Charitable Trust conducted an assessment of perspectives across the US pharmaceutical supply chain in 2013 and issued a report in late April 2014. Key findings from the study included the lack of […]

FDA Proposes Reg on Drug Destruction at Border

In early May, FDA proposed a rule spelling out its right to destroy drugs at the border as part of its implementation of section 708 of FDASIA (see IPQ October 24, 2013 and January 23, 2014). In order to better meet the needs of a secure supply chain FDA would now be allowed to destroy […]
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